Brand Name | FLIXENE VASCULAR GRAFT |
Type of Device | PROSTHESIS, VASCULAR GRAFT |
Manufacturer (Section D) |
ATRIUM MEDICAL CORP. |
hudson NH |
|
Manufacturer Contact |
lori
gosselin, sr. compl coord
|
5 wentworth dr. |
hudson, NH 03051
|
6038801433
|
|
MDR Report Key | 4683675 |
MDR Text Key | 20016509 |
Report Number | 1219977-2015-00116 |
Device Sequence Number | 1 |
Product Code |
DSY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K071923 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/27/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/31/2016 |
Device Model Number | 25061 |
Device Catalogue Number | 25061 |
Device Lot Number | AK33551 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/27/2015
|
Initial Date FDA Received | 04/10/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2011 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 29 YR |
Patient Weight | 43 |
|
|